Federal Register
Notice: FDA has determined the regulatory review period for Elan Pharmaceuticals’ Prialt (ziconotide) is 3,801 days for extending two patents which claim the human drug product. Prialt is indicated for managing severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine. To view this notice, click here.